Clinical Trial · NCT00721799

F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients

Overview

This is an imaging protocol only, not a therapeutic study. The primary goal of the proposed study is to examine the utility of a new imaging study, Positron Emission Tomography with F-18 Fluorothymidine (FLT PET), in the early treatment evaluation of head and neck cancer. FLT uptake in the tumor correlates with the rate of cell proliferation. It is therefore hoped that changes in tumor FLT uptake after therapy will reflect change in the number of actively dividing tumor cells and will provide early assessment of treatment response. Research subjects will undergo one PET scan with FLT. The scan is done prior to any therapeutic intervention (radiation or chemotherapy) can be obtained up to 30 days prior to the start of therapy. The uptake of FLT in the tumor will be analyzed to see if it can be used as a predictor of treatment efficacy and/or outcome. There is an optional biopsy component to this study. Should the attending physicians (primarily the otolaryngologists) believe that the subject can safely undergo an outpatient biopsy, and the subject agrees, a biopsy is performed. The biopsy will be done within 30 days prior to treatment, similar to FLT PET scans. Tissue from the biopsy will be analyzed for markers of cellular proliferation and these markers will be correlated with the findings of FLT PET scan. There will be a 2-year clinical follow-up to assess for treatment outcomes, local control, and overall survival.

Sponsor

University of Iowa

Phase

Phase 2

Contacts

Yusuf Menda, M.D. (PRINCIPAL_INVESTIGATOR)

John M. Buatti, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00721799

Drug / Compound

Fluorothymidine

Isotope(s):

Target(s):

cytosolic thymidine kinase 1

Ligand Class: Small Molecules

Eligibility

Inclusion

total bilirubin ≤ 1.0 mg/dl\*
Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:
Life expectancy of greater than 6 months.
PT and PTT (if biopsy is to be performed) \< 2.0 X upper normal limits
creatinine ≤ 1.5 x institutional upper limit of normal
platelets ≥ 100,000/μL
The effects of FLT on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine hCG will be administered in the Nuclear Medicine to women of childbearing potential before each FLT scan and pregnant women will not be accepted as subjects in this study.
absolute neutrophil count ≥1,500/μL
Karnofsky greater than or equal to 60% at time of screening.
Subject must be scheduled to receive combined chemo-radiotherapy treatment for their standard cancer care. Treatment decisions will be made by the treating otolaryngologist, radiation, and medical oncologists.
leukocytes ≥ 3,000/μL
Either AST OR ALT ≤ 2.5 X institutional upper limit of normal

Exclusion

Subject may not be receiving any other investigational agents.
Subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Pregnant women are excluded from this study. FLT PET has potential for teratogenic effects. Because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with FLT, breastfeeding should be discontinued if the mother is imaged with FLT and may not resume for 48 hours after the FLT imaging.
Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Subject with a Karnofsky score of below 60.